Intermittent vectored digital manipulation device and method

ABSTRACT

Footwear that includes an interdigital boss that is positioned on the footwear and extends upward from a sole of the footwear in a configuration and direction that is more anatomically correct than an improperly positioned digit of a wearer of the footwear so as to provide intermittent corrective forces on the wearer&#39;s foot as the wearer walks that prevent bunions from forming on the wearer&#39;s foot. The boss provides a slight corrective motion during load bearing and a non-correcting position during the swing phase of the gait cycle of the wearer so as to stretch soft tissues in the wearer&#39;s foot, to provide pain relief, and to delay or prevent the onset of degenerative diseases, such as bunions. The boss causes corrective forces to be exerted on the tissues intermittently, thus eliminating the dull ache experienced by constant corrective devices.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application claims the benefit of the filing date of U.S. Provisional Patent Application No. 62/601,756 filed Mar. 31, 2017, and titled Intermittent Vectored Digital Manipulation Device and Method.

BACKGROUND Field

This disclosure relates generally to footwear that provides intermittent corrective motion during ambulation and, more particularly, to footwear that includes a raised boss configured to be positioned between toes of the foot of a wearer of the footwear that provides intermittent corrective motion during ambulation so as to prevent bunions from forming.

Discussion

The human foot is a complex structure of bones and tendons. The bones of the fore-foot from the tip of the toe rearwards include phalanges, specifically three in the lesser toes and two in the hallux and metatarsals, where the mid-foot bones include cuneiforms and cuboid. The function of the foot is controlled partially by a large tendon complex referred to as the plantar tendon that controls the arch height of the foot, and locks and unlocks the foot during the gait cycle, where the plantar tendon is routed between the sesamoids to be attached to the hallux. There are numerous smaller tendons attached to the bones of the foot to control position and function.

Bunions, referred to in the medical community as hallux valgus (HV), are a common and painful foot condition often times removed by surgery. Bunions typically occur in the first ray, also known as the big toe or hallux, but can also occur in the fifth ray, although less common. Bunions generally occur when the toe joint moves medially, which sometimes causes a large bump in the foot. More specifically, if the deep transverse metatarsal ligament ruptures, the hallux migrates laterally, and the plantar tendon force vector crosses the center of the metatarsal-phalangeal joint, where rotation is accelerated creating the bunion. Bunions cause shoe fit problems, alter the walking mechanism, and create pain for the individual. The etiology is primarily genetic where minor differences in bone structure suggests a predictor of developing bunions, which are accelerated by narrow toe shoes, common in the western hemisphere.

Professionals in the art have noted the need to address hallux valgus and providing corrective measures prior to the current standard of letting the disease progress, necessitating bunion surgery, which is essentially a salvage procedure.

There are numerous non-operative treatments that address bunions that can move the hallux into its proper position. These treatments can be categorized as fixed displacement (static), or variable displacement (dynamic) procedures. Fixed displacement procedures generally require the individual to wear splints at night that are anchored to the mid-foot. Another approach includes wearing a series of silicone toe spreaders that are worn when convenient, but which are bulky and often cannot be used during daily activities. Variable displacement devices typically have elastic members that tension the hallux in an attempt to put it back into alignment. Both static and dynamic splints apply constant force on the hallux, where the pain receptors in the foot are constantly active. Compliance with these devices is low due to constant pain. Often times these devices are only used in the evening, where the time of treatment is further reduced. Other foot problems, such as plantar fasciitis, are treated with dynamic splints that are even more bulky, and have the same limitations as static splints. A shoe or sneaker that fits well does not fit as well as one may think. Typically, there is wiggle room in the toe box, which is a common test performed during footwear fitting.

The human gait has phases that include the contact phase where the foot is on the ground and sub-categories that include first a heel strike, then mid-stance where the load center travels along the foot, propulsion or toe off, and then the swing phase. The running phases may have alternate strike locations, but are individual specific.

There are fat pads under the bones of the forefoot that function as cushioning elements. During the gait cycle, they are compressed when loaded, and like springs, return to a taller height when unloaded. Indentation of the pads can be numerous millimeters deep during compression. Under the first metatarsal head, the pad thickness is 8.5±1.5 mm, but lessens with hallux valgus to 7.4±1.6 mm. The toes and to a lesser extent rises off insole 1 to 2 mm during the swing phase of the gait cycle. Coupled with the compression of the fat pads, the metatarsals in the toes rise is a combination of the toe box lift, and fat pad displacement, for a total range of motion of 5 mm or more.

SUMMARY

The present disclosure describes footwear that provides intermittent corrective motion during ambulation to prevent bunions from forming. The footwear includes an interdigital boss that is positioned on the footwear in a direction that is more anatomically correct than the improperly positioned digit of the footwear wearer. The boss provides a slight corrective motion during load bearing and a non-correcting position during the swing phase of the gait cycle so as to stretch soft tissues, to provide pain relief, and to delay the onset of degenerative diseases. The corrective forces are exerted on the tissues intermittently, thus eliminating the dull ache experienced by constant corrective devices.

In one embodiment, the footwear includes an insole, either integral to a shoe or sandal or as a separate and removable insert, and an integral boss that extends from the plantar contact surface of the wearer's foot, towards the dorsal surface of the hallux. The boss includes an oblique surface adjacent to the hallux that contacts the lateral side of the hallux during all phases of the wearer's gait cycle, where during the gait cycle the small vertical motion of the hallux results in a distraction of the hallux towards a more anatomical position. The boss produces the opposite motion to what happens to the foot digits in pointed shoes. In another embodiment, the footwear includes an under-foot sole with at least one boss extending above the foot contact surface that is in the projected inter-toe space when the wearer's foot is in the swing phase of the gait cycle, and having at least one surface angled from the vertical plane to intersect the toe during the loaded phase of the gait cycle, creating an intermittent motion of the toe during ambulation.

Additional features of the present disclosure will become apparent from the following description and appended claims, taken in conjunction with the accompanying drawings.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is an isometric view of a footwear including an interdigital boss module;

FIG. 2 is a side view of the interdigital boss module shown in FIG. 1 separated from the footwear;

FIG. 3 is a top view of an insole including another interdigital boss module;

FIG. 4 is an isometric view of an insole including another interdigital boss module; and

FIG. 5 is an isometric view of another interdigital boss module separated from the footwear.

DETAILED DESCRIPTION OF THE EMBODIMENTS

The following discussion of the embodiments of the disclosure directed to footwear that includes a raised boss configured to be positioned between toes of the foot of a wearer of the footwear that provides intermittent corrective motion during ambulation so as to prevent bunions from forming is merely exemplary in nature, and is in no way intended to limit the invention or its applications or uses.

The present disclosure proposes a device that is part of a shoe or sandal that operates to provide a slight corrective motion during load bearing and a non-correcting position during the swing phase of the gait cycle to prevent a bunion from forming on the wearer's foot. The device will treat women and men that are developing hallux valgus due to genetic causes or otherwise. Treatment of women in their second and third decade may retard the onset or progression of hallux valgus by giving the ligaments and soft tissues correct positioning without pain or intrusion into lifestyle or habits. To prevent pain, translation of the metatarsals by the device is very small in both angular and linear displacements. The use of the device may prevent advancement of hallux valgus as it unloads the deep transverse metatarsal ligament. Even when the joint is incongruent, the device can assist in pushing the joint back towards a congruent location, and may provide considerable pain relief. Intermittent stretching of the toe is much less painful than constant distraction. Soft tissues would distract as well, though the treatment is slow and generally regarded as painful.

There are several locations on the human foot that the device is useful to correct the more common hallux valgus, and the similar condition of the fifth metatarsal. The Hallux valgus can use one or two corrective ramps. The two-boss system has a medial boss to the laterally displaced joint, and the lateral boss to the medially displaced joint. There is variation in the hallux width, IMA, stiffness, and interdigital space depth and width. To accommodate these variations in people, the position, angle and height of the device must be varied so distraction distance and forces are small. A modular insole version of the device allows a single geometric sole to be mated with a selectable module with varied parameters. The modules can be either bottom or distal loading, going into a receiving recess. Interlocking means can be employed, typically barbs or latches, to prevent mobile boss migration. A lateral offset positioner and scale, a distal slide positioner and scale, both to locate the terminus of the hallux, second digit interspace, and an angle of the lateral hallux relative to the sagittal plane. Similar measurements can be taken for the other distraction boss locations. These three measurements determine the location and angle of the distraction boss.

FIG. 1 is an isometric view of a footwear 10, specifically a sandal for a left foot (not shown) of the wearer, that includes a sole 12 that is intended to represent any type of sole that is part of a sandal or an insole typically found inside many types of shoes, sneakers, boots, etc. The sole 12 includes a top region 14, a lateral side 16, a medial side 18, a heel region 20 where the back of the foot of the wearer contacts the sole 12, a front region 22 where the toes of the wearer contact the sole 12, and a mid-region 24 including an arch support 26 that is raised for supporting the medial arch of the mid-foot of the wearer. The arch support 26 is positioned for locating the middle region of the wearer's foot, where some soles and insoles may not have an arch support. The footwear 10 is held onto the wearer's foot by a strap 30 and includes a latchet 32 for better control of the foot's position, where the wearer's toes are positioned on either side of the latchet 32.

The footwear 10 includes an interdigital boss module 40 mounted to the sole 12 in the front region 22 so that it will be positioned between the first and second toes of the wearer in a direction that is more anatomically correct than the improperly positioned digit of the footwear wearer and provide intermittent corrective forces on the wearer's foot consistent with the discussion herein. FIG. 2 is a side view of the module 40 separated from the footwear 10. The module 40 is an integrated single piece member that includes a base portion 42 and a fin-shaped interdigital boss 44, where the base portion 42 is secured to the sole 12 in any suitable manner, such as by glue. Alternately, the module 40 can be integrated into the sole 12, where the footwear 10 itself would be an orthopedic device. The module 40 can be rigid or semi-rigid and be made of any suitable material, such as a molded plastic, for example, PEEK, UHMW, etc. The boss 44 extends upward from the front region 22 of the sole 12 to be positioned in a direction that is more anatomically correct than the improperly positioned digits of the footwear wearer of the foot of the wearer for the reasons discussed herein. The base portion 42 includes curved sides 46 that conform to the anatomy of the wearer's foot and provide greater wearer comfort. The boss 44 includes a generally rounded and tapered body 48 in both a front-to-back direction and a side-to-side direction to also conform to the wearer's foot anatomy, and is generally an elongated upside down cut-off cone.

The module 40 can be provided in various sizes and shapes to be able to be worn by different people of different sizes having different anatomies, to be configurable for different types of footwear and to be configured for different toes. For example, the boss 44 can be taller for open type shoes and can be shorter for certain types of shoes and boots, where the boss 44 will typically be 2-2.5 mm in height. Further, the boss 44 can be asymmetrical, where, for example, a medial side of the boss 44 has a curvilinear shape. Also, the boss 44 can be angled or rotated relative to the base portion 42.

FIG. 3 is a top view of an insole 50 that has been removed from a shoe or boot (not shown) and includes a top surface 52 having an arch support 54 on a medial side 56 of the insole 50. The insole 50 further includes an interdigital boss module 60 of the type discussed above that is mounted to the top surface 52. The module 60 includes a base portion 62 having a general curvilinear shape and being secured to the top surface 52 of the insole 50. The module 60 also includes an interdigital boss 64 that also has a general curvilinear shape that generally follows the contour of the base portion 62, where medial surfaces 66 and 68 of the base portion 62 and the boss 64, respectively, are indented, as shown.

FIG. 4 is an isometric view of an insole 70 that has been removed from a shoe or boot (not shown) and having a top surface 72 with an arch support 74 on a medial side 76 of the insole 70. The insole 70 includes an interdigital boss module 80 of the type discussed above. The module 80 includes an elliptical-shaped base portion 82 that has flat sides 84 and a flat top surface 86 instead of the contoured shape of the embodiments discussed above. The base portion 82 is positioned within a cut-out opening 90 in the top surface 72 of the insole 70. In this embodiment, the top surface 86 of the base portion 82 is flush with the top surface 72 of the insole 70 so that the wearer's foot rests on the top surface 86. Although the opening 90 is shown as being elliptical-shaped in this embodiment, it can have any shape suitable for a particular footwear, such as circular. The opening 90 can also conform exactly to the shape and size of the base portion 82. The module 80 also includes a fin-shaped boss 88 formed to the base portion 82 and having a body 92 with a straight front edge 94 and a curved back edge 96.

FIG. 5 is an isometric view of an interdigital boss module 100 separated from the footwear and being similar to the module 80, where like elements are identified by the same reference number. In this embodiment, the boss 88 is replaced with an interdigital boss 102 including a tapered body 104 that is angled in a medial-lateral direction relative to the base portion 82, as shown. Any suitable angle can be provided, such as 5, 7.5 and 15 degrees, relative to a center line of the footwear. The body 104 includes an upper region 110, a middle region 112 and a correct region 114. Further, the module 100 includes an elliptical mounting flange 106 having the same general configuration as the base portion 82, although other shapes may work equally well, and being formed to a bottom surface of the base portion 82. The flange 106 is operable to be secured to a bottom surface of a sole or insole of the footwear so that the module 100 can be attached from a bottom of the footwear where the base portion 88 would be positioned within an opening in the sole or insole and the boss 102 would extend upward from a top surface of the sole or insole.

The upper region 110 of the body 104 is where a lateral surface of the wearer's big toe contacts the boss 102 during the swing phase of the gait cycle. When the wearer's foot is in contact with the ground, and his/her weight is distributed on it, the fat pads of the toes compress, and any space in the footwear as a result of a slightly loose fit is taken up and the toes slides past the middle region 112 to the correct position 114.

The foregoing discussion discloses and describes merely exemplary embodiments of the present disclosure. One skilled in the art will readily recognize from such discussion and from the accompanying drawings and claims that various changes, modifications and variations can be made therein without departing from the spirit and scope of the disclosure as defined in the following claims. 

What is claimed is:
 1. Footwear comprising: a sole including a back portion, a front portion and a middle portion; and an interdigital boss module mounted to the front portion of the sole, said boss module including a base portion in contact with the front portion and a fin-shaped interdigital boss extending from a top surface of the sole and being configured to be positioned relative to a foot of a wearer of the footwear so as to provide intermittent corrective forces on the wearer's foot as the wearer walks that medially distracts a big toe of the wearer's foot, which prevents bunions from forming or advancing on the wearer's foot.
 2. The footwear according to claim 1 wherein the interdigital boss module is an integrated single piece member.
 3. The footwear according to claim 2 wherein the base portion has a general tapered shape from the top surface to the boss and the boss has a general tapered shape from side-to-side and front-to-back.
 4. The footwear according to claim 2 wherein the interdigital boss module is a plastic member.
 5. The footwear according to claim 1 wherein the base portion is secured to the top surface of the sole.
 6. The footwear according to claim 1 wherein the base portion is positioned within a cut-out opening in the sole.
 7. The footwear according to claim 6 wherein the base portion has a flat top surface that is flush with the top surface of the sole.
 8. The footwear according to claim 6 wherein the boss module further includes a flange secured to a bottom surface of the base portion and being mounted to a bottom surface of the sole.
 9. The footwear according to claim 1 wherein the base portion and the boss include an indentation on a medial side of the footwear.
 10. The footwear according to claim 1 wherein the boss is angled relative to the base portion and a medial-lateral orientation of the footwear.
 11. The footwear according to claim 1 wherein the boss includes a straight front edge and a curve back edge.
 12. The footwear according to claim 1 wherein the footwear is a sandal, shoe or boot.
 13. Footwear comprising: a sole including a back portion, a front portion and a middle portion; and an interdigital boss module mounted to the front portion of the sole, said boss module including a base portion in contact with the front portion and a fin-shaped interdigital boss extending from a top surface of the sole and being configured to be positioned relative to a foot of a wearer of the footwear so as to provide intermittent corrective forces on the wearer's foot as the wearer walks that medially distracts a big toe of the wearer's foot, which prevents bunions from forming or advancing on the wearer's foot, wherein the base portion has a general tapered shape from the top surface to the boss and the boss has a general tapered shape from side-to-side and front-to-back, and wherein the boss is angled relative to the base portion and a medial-lateral orientation of the footwear.
 14. The footwear according to claim 13 wherein the base portion is secured to the top surface of the sole.
 15. The footwear according to claim 13 wherein the base portion is positioned within a cut-out opening in the sole.
 16. The footwear according to claim 15 wherein the base portion has a flat top surface that is flush with the top surface of the sole.
 17. The footwear according to claim 15 wherein the boss module further includes a flange secured to a bottom surface of the base portion and being mounted to a bottom surface of the sole.
 18. The footwear according to claim 13 wherein the base portion and the boss include an indentation on a medial side of the footwear.
 19. Footwear comprising: a sole including a back portion, a front portion and a middle portion; and a single plastic piece interdigital boss module mounted to the front portion of the sole, said boss module including a base portion in contact with the front portion and a fin-shaped interdigital boss extending from a top surface of the sole and being configured to be positioned relative to a foot of a wearer of the footwear so as to provide intermittent corrective forces on the wearer's foot as the wearer walks that medially distracts a big toe of the wearer's foot, which prevents bunions from forming or advancing on the wearer's foot, wherein the base portion has a general tapered shape from the top surface to the boss and the boss has a general tapered shape from side-to-side and front-to-back, and wherein the base portion is positioned within a cut-out opening in the sole.
 20. The footwear according to claim 19 wherein the base portion has a flat top surface that is flush with the top surface of the sole. 